BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR LASER SYSTEM

    MDR report key: 639650 · Received October 3, 2005

    Report

    Report Number
    2950711-2005-00002
    Event Type
    Injury
    Date Received
    October 3, 2005
    Date of Event
    September 2, 2005
    Report Date
    October 2, 2005
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 05, PT WAS REPORTED TO HAVE DEVELOPED AN INFECTION IN THE AREA TREATED BY THE FRAXEL SR LASER SYSTEM. THE PT RECEIVED TWO TREATMENTS WITH THE FRAXEL SR LASER SYSTEM, WITH THE SECOND TREATMENT ADMINISTERED IN 08/05. FOLLOWING TREATMENT TWO, PT REPORTED PEELING BILATORALLY UNDER THEIR EYES. 24 HOURS POST-TREATMENT, THE TREATING PHYSICIAN SUSPECTED A POSSIBLE INFECTION IN THE INFRAORBITAL REGION. THE PHYSICIAN INSTRUCTED THE PT TO APPLY SILVADENE, A TOPICAL ANTIBIOTIC, 5 TIMES A DAY. IN ADDITION, THE PT WAS PROVIDED WITH 150 MG OF DIFLUCAN 6 DAYS LATER. FOUR DAYS LATER, THE PHYSICIAN PRESCRIBED CIPROFLEXACIN. CULTURE RESULTS FROM A SAMPLE TAKEN WITHIN THE INFRAORBITAL REGION PERFORMED THAT SAME DAY CONFIRMED MODERATE GROWTH OF STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL SR LASER SYSTEM SURGICAL LASER GEX RELIANT TECHNOLOGIES, INC. 00-00609 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other